FDA Clearance + Compliance Foundation for International Manufacturers
A structured, phased program to achieve U.S. FDA market access—built for portfolio execution, predictable budgets, and inspection-ready operations under QMSR.
Built for EU MDR / ISO 13485 manufacturers, orthopedic implants, surgical devices, and scalable U.S. entry programs.
Who This Program Is For
We designed this program for serious operators seeking U.S. market access with a durable compliance backbone.
International Manufacturers
EU, UK, and global manufacturers entering the U.S. market for the first time or expanding product lines.
- EU MDR / ISO 13485 documentation leverage
- U.S. Agent + registration/listing readiness
- Time-zone friendly coordination
Implant & Surgical Portfolios
Orthopedic, spine, trauma, extremity, and procedure-driven device families that benefit from portfolio sequencing.
- Multi-line predicate architecture
- Shared testing strategy
- Submission roadmap (3–5+ filings)
Funded Device Companies
Teams who need an execution partner, not strategy-only consulting who can drive to submission and clearance support.
- Operational cadence + ownership
- eSTAR-ready compilation
- AI response management
Not sure if you fit?
We’ll tell you quickly if a 510(k) pathway is appropriate, how many filings your portfolio likely requires, and what the fastest credible plan looks like.
The 4-Pillar U.S. Entry Model
A coordinated program reduces total regulatory spend and accelerates market access—especially for multi-line portfolios.
1) Classification & Product Code Mapping
We analyze each device family against FDA’s classification framework and product code expectations to identify the correct pathway, data needs, and reviewer context.
- Product code and regulation mapping
- Device family segmentation and scope boundaries
- Early risk identification (RTA / data gaps)
2) Predicate Architecture & SE Strategy
We design predicate selection and substantial equivalence arguments to support review efficiency and reduce rework across submissions.
- Predicate shortlist + rationale
- SE comparison matrix + technological characteristics
- Multi-predicate strategy when needed
3) Testing Reuse & Evidence Strategy
Where materials, design characteristics, and intended use overlap, we build a master evidence plan to reduce redundant testing across portfolio submissions.
- Standards mapping (ASTM / ISO / FDA-recognized)
- Gap analysis: what you have vs. what FDA expects
- Protocol recommendations + lab coordination support
4) QMSR + Inspection-Ready Operations
QMSR is now the baseline for U.S. quality compliance. We align submission-facing documentation and operating processes so you’re ready for U.S. obligations post-clearance.
- QMSR gap analysis + prioritized remediation
- Medical Device File (MDF) documentation alignment
- UDI / MDR reporting / labeling readiness
Detailed Services Included
Designed to eliminate ambiguity and protect timelines. Scope is sequenced so each phase produces tangible outputs and decision points.
Intended use framing, device family scope definition, classification mapping, and initial regulatory pathway alignment.
Predicate selection, SE comparison matrix, technological characteristics narrative, and argument architecture.
Standards mapping, review of existing evidence, identification of gaps, and recommended testing protocols.
End-to-end drafting and assembly into a submission-ready package, aligned to eSTAR and RTA expectations.
510(k) Execution to Completion
- Device description + intended use / indications alignment
- Performance testing summary and rationale
- Biocompatibility summary (from existing evidence)
- Labeling review and U.S. compliance alignment
- eSTAR formatting and submission packaging
- FDA review support + AI response drafting support
U.S. Market Entry Infrastructure
- U.S. Agent designation support (foreign manufacturer requirement)
- Establishment Registration + Device Listing support
- Small business qualification support (if eligible)
- QMSR gap analysis + inspection readiness alignment
- Portfolio sequencing plan (for multi-line programs)
Want the fastest credible path?
We’ll review your portfolio, identify submission count drivers, and propose a phased roadmap aligned to commercial priorities and evidence readiness.
Key Deliverables
These are the outputs you can circulate internally (leadership, QA, R&D, labs, distributors) to keep alignment tight and decisions fast.
Classification & Portfolio Map
A device-family segmentation and product code map used to define submission count and sequencing.
- Device family boundaries
- Product code candidates
- Submission sequencing recommendations
Predicate & SE Dossier
Predicate shortlist, selection rationale, and a structured SE comparison framework designed for reviewer clarity.
- Predicate decision logic
- SE comparison matrix
- Argument architecture
Master Evidence Plan
A testing and documentation reuse strategy that reduces duplication and avoids late surprises.
- Standards mapping
- Evidence gaps + protocols
- Reuse opportunities across filings
Submission-Ready eSTAR Package
A complete, organized 510(k) package aligned to RTA expectations and reviewer consumption.
- Full 807.87 section coverage
- Clear cross-referencing
- Coherent narrative + tables
QMSR Alignment Pack
Targeted QMSR transition support built around your existing ISO 13485 system, with U.S.-specific requirements addressed.
- QMSR gap analysis
- MDF alignment approach
- UDI / MDR reporting readiness
FDA Review Support
Support through the review cycle, including packaging of responses to keep timelines and approvals moving.
- AI request triage
- Draft responses + exhibits
- Review cadence and tracking
Indicative Timeline
Actual timelines depend on document completeness and evidence readiness, but our execution model is built to move fast once intake is complete.
Single Device Family (Typical)
- Week 1: assessment, classification, predicate shortlist
- Week 2: SE matrix + evidence plan
- Weeks 3–4: drafting + assembly + internal review
- Submission: eSTAR package filed upon approval
- FDA Review: typically ~90 days (subject to AI pauses)
Portfolio Program (Phased)
- Phase 0: portfolio map + sequencing (fast alignment)
- Phase 1: establish first clearance (creates predicate leverage)
- Phase 2+: roll filings using reused evidence/templates
- Cadence: 3–5 submissions over 18–36 months (typical)
- Outcome: compounding efficiency and lower total spend
Let’s define your submission count and sequencing.
In a single session, we can identify likely submission families, predicate strategy options, and an evidence plan that supports a phased clearance roadmap.
Why Verus FDA
International manufacturers need more than “advice.” They need an execution partner who understands reviewer expectations and drives to completion.
Execution to Completion
We own the workstream—from strategy to submission packaging to review support—so you don’t get stuck with half-built deliverables.
- Clear process + accountability
- Submission-ready outputs
- Review-cycle support
Portfolio-Level Thinking
We build predicate architecture and evidence reuse strategies so each submission strengthens the next.
- Sequenced clearances
- Reusable templates
- Reduced duplication
QMSR + Inspection Readiness
Clearance is not the finish line. QMSR and inspection readiness are part of market entry—so we embed it from day one.
- QMSR gap analysis
- MDF documentation alignment
- U.S.-specific obligations
Note: Third-party costs (FDA user fees, laboratory testing, registration fees) are separate from professional services and are always confirmed in writing prior to commitment.
Frequently Asked Questions
Common questions from EU MDR / ISO 13485 manufacturers entering the United States market.
Do we need a U.S. distributor before filing a 510(k)?
No. A distributor is not required to file or receive a 510(k). Foreign manufacturers do need a U.S. Agent and FDA Establishment Registration and Device Listing prior to submission acceptance and commercialization.
Can we pursue U.S. clearance while EU MDR work is ongoing?
Yes. EU MDR and FDA 510(k) are independent processes and are often executed in parallel to accelerate time-to-market. Existing ISO 13485 documentation can provide strong foundational leverage.
How does QMSR impact submissions and inspections?
QMSR incorporates ISO 13485:2016 by reference into 21 CFR Part 820 and changes inspection expectations. We align submission-facing documentation and quality processes so you are prepared for U.S. compliance obligations after clearance.
What happens if FDA issues an Additional Information (AI) request?
AI pauses the review clock until a response is submitted. We help draft and package responses with supporting exhibits so review can restart quickly and the request scope stays contained.
How many 510(k)s will our portfolio require?
It depends on device family boundaries (intended use, design, material platform, technology). Closely related variants and some accessory/instrumentation sets may be included within a single submission. We provide a recommended submission count after portfolio mapping.
Request a Portfolio Review
Send a short summary of your device families and priorities. We’ll respond within one U.S. business day to schedule the next step.
What to Include
- Device family list (or product catalog)
- Intended use / indications (draft is fine)
- Materials and sterilization method (if applicable)
- Existing test evidence (mechanical, biocompatibility, etc.)
- Commercial priorities + target launch timing
Tip: For international teams, include preferred meeting windows in CET/UTC and we’ll accommodate.
What You’ll Get After the Call
- Likely submission count drivers and family boundaries
- Initial predicate strategy direction
- Evidence plan outline + likely testing gaps
- Phased roadmap aligned to commercial priorities
- Fixed scope proposal for Option A (single family) or Option B (portfolio program)
This page is informational and does not constitute legal advice. Engagement begins only after a mutually executed agreement.